University of Minnesota - Clinical and Translational Science Institute

ClinicalTrials.gov Identifier:

NCT01797367

First Posted: February 22, 2013

Last Update Posted: January 23, 2017

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Information provided by (Responsible Party):

University of Minnesota - Clinical and Translational Science Institute

The purpose of this study is to find out if starting anti-retroviral therapy (ART) above 500 cluster-of-differentiation-4 (CD4)+ cells/milliliter (mL) ('early ART group') slows the rate of decrease in lung function over time compared to waiting to start ART until the CD4+ drops below 350 cells/mL ('deferred ART group'). Lung function normally declines with age, and both human immunodeficiency virus (HIV) infection and ART have been shown to case a decline in lung function as well. Decline in lung function can be an early indicator of chronic obstructive pulmonary disease (COPD), a significant cause of sickness and death in people with HIV. In this study, lung function will be measured at baseline and every year thereafter by using a spirometer.

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:

Change from baseline in post-bronchodilator forced expiratory volume in 1 second (FEV1) [ Time Frame: baseline, then at annual visits for up to 6 years ]

FEV1 is measured by having the participant inhale a dose of bronchodilator (albuterol/salbutamol), wait 15 minutes, and then inhale maximally and exhale maximally and forcefully into a spirometer. Participants do at least 3 trials of spirometry for each measurement, and up to 8, to obtain 3 usable measurements.

Secondary Outcome Measures:

Change from baseline in respiratory health status using the St. George's Respiratory Questionnaire for COPD (SGRQ-C) [ Time Frame: baseline, then at annual visits for up to 6 years ]

The SGRQ-C is a standardized, validated, self-administered questionnaire that measures respiratory health status and includes domains of respiratory symptoms, activity limitations, and psychosocial impact. It will be given to participants to complete in their native language. It contains 40 items and takes approximately 10-15 minutes to complete.

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An episode of respiratory illness with 2 or more symptoms of cough, wheezing, breathlessness, or increase in sputum production within the 6 weeks before baseline spirometry.

Use of asthma medications (bronchodilator, inhaled corticosteroid, leukotriene inhibitor, or theophylline) for 2 or more consecutive weeks within the 6 months before baseline spirometry.

Relative contraindications to spirometry, such as chest or abdominal or eye surgery within the 3 months before baseline spirometry, known retinal detachment at the time of baseline spirometry.

Known allergy to albuterol/salbutamol

Relative contraindications to albuterol/salbutamol, such as resting heart rate of >110 beats per minute, or a known serious or recurrent or uncontrolled cardiac condition (such as unstable coronary artery disease, decompensated heart failure, or recurrent tachyarrhythmias).

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01797367

Locations

United States, District of Columbia

Washington DC VA Medical Center

Washington, District of Columbia, United States, 20422

Sponsors and Collaborators

University of Minnesota - Clinical and Translational Science Institute

Investigators

Study Chair:

Ken M Kunisaki, MD

Minneapolis Veterans Affairs Medical Center

Study Chair:

Dennis E Niewoehner, MD

University of Minnesota - Clinical and Translational Science Institute

Study Chair:

John E Connett, PhD

University of Minnesota - Clinical and Translational Science Institute